EDC Programmer with SDTM CDISC XML / Data Standards Programmer (May work remotely) Job in Boston North 02451, Massachusetts US

PAREXEL International is a growing, fast-paced, global Clinical Research Organization (CRO) that has helped bring to market 49 of the top 50 selling pharmaceuticals. In fact, we have worked with all 10 of the world's top 10 pharmaceutical companies.

Given our breadth of expertise and the trust placed in us by major pharmaceutical companies worldwide, PAREXEL can provide you with a number of career options in Clinical Research that can rarely be found within just one company. In fact, over 25% of the positions opened at PAREXEL are filled by current employees working to advance their skills and careers.

Principal Data Standards Programmer SDTM CDISC (eClinical, EDC, IVRS, ePRO, CTMS, XML)

Remote work arrangements are possible

Do you possess cutting edge clinical systems programming expertise and a keen understanding of clinical data standards? Do you have what it takes to be part of a high growth team? Come to an industry leader where you will have the opportunity to function as a subject matter expert for industry and sponsor specific data standards and technology projects. Meet with internal/external software vendors to lead technical activities for the data exchange process on projects involving multiple systems with complex technology requirements. Provide technical data standards leadership and consultation, stakeholder management, external client support, and project management for technical aspects supporting data standards in clinical trial operational activities.

Ideal candidates must be well versed in XML (including XML schema), knowledgeable about data standards in clinical trial environments, specifically CDISC models (ODM, SDTM, CDASH, Define.xml, etc.). In addition to possessing experience in clinical trial systems (such as EDC, ePRO, IVRS, or CTMS), you will be familiar with the overall clinical trial processes, business process redesign / business process improvement, 21 CFR Part 11, and ICH-GCP standards.

GROWTH:
While most companies were busy downsizing, during 2010 PAREXEL opened two new offices and added over 800 employees!

PROMOTION:
In 2010, more than 1700 PAREXEL employees received career promotions!!

EXPERTISE:
PAREXEL's experts, who have experience across a broad range of therapeutic areas, have supported nearly all of the top 50 best-selling drugs that are on the market today.

AWARDS:
PAREXEL was named Company of the Year 2010 for the Pharmaceutical Industry in The Eighth Annual International Business Awards, the only global, all-encompassing business awards program honoring great performances in business.
PAREXEL announced that the Company had been included on the 'Best 5'Pharmaceutical' industry sublist 2010 as part of The International Association of Outsourcing Professionals® (IAOP®) annual ranking The Global Outsourcing 100.
PAREXEL was recognized as a Best 10 Outsourcing Company for the Pharmaceutical Industry as part of the Global Outsourcing 100® 2010, and also received Scrip Award for Clinical Research Team of the Year.
PAREXEL was recognized as Best Performing CRO 2009 by BioSingapore for its leadership in the Asia/Pacific region, and ranked in the Top 10 among best performing Massachusetts-based public companies in The Boston Globe 100, as well as a Top Employer (ranked by number of worldwide employees)

Keywords: CDISC, ODM, SDTM, CDASH, xml, EDC, ePRO, IVRS, CTMS, 21 CFR Part 11, ICH, GCP, SAS, Perl, Python, UNIX shells, eClinical, Biostatistics, Data Management, Clinical Database Programming, Records Management, Statistical Analysis and Reporting, Data operations, interactive voice response systems, rave, inform, datalabs, trialworks, clinphone, perceptive informatics, clinical research, clinical trial, clinical trail, clinical study, CRO, pharmaceutical, biotechnology, biotech, medical device

-5 to 8 years of programming experience in life sciences industry (Pharmaceutical or Clinical Research Organization)
-Data modeling or business analysis experience
-Knowledge of CDISC models
-Experience in clinical database systems (CDBMS) or web based clinical trials (EDC)
-Solid presentation and communication skills in both internal and client facing roles

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